Study of Vadastuximab Talirine (SGN-CD33A; 33A) in Combination With Azacitidine in Patients With Previously Untreated Higher Risk MDS
NCT ID: NCT02706899
Last Updated: 2019-02-12
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
19 participants
INTERVENTIONAL
2016-02-29
2017-11-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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33A + azacitidine
Vadastuximab talirine plus azacitidine
vadastuximab talirine
Intravenous (IV) push every 4 weeks
Azacitidine
75 mg/m\^2 given intravenously or subcutaneously for 7 days every 4 weeks
Placebo + azacitidine
placebo plus azacitidine
Azacitidine
75 mg/m\^2 given intravenously or subcutaneously for 7 days every 4 weeks
Placebo (for 33A)
Placebo supplied in single-use vials matching 33A, IV push every 4 weeks
Interventions
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vadastuximab talirine
Intravenous (IV) push every 4 weeks
Azacitidine
75 mg/m\^2 given intravenously or subcutaneously for 7 days every 4 weeks
Placebo (for 33A)
Placebo supplied in single-use vials matching 33A, IV push every 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Previously untreated for Myelodysplastic Syndrome (MDS)
* Age ≥18 years of age.
* Eligible for therapy with azacitidine.
* Life expectancy of at least 12 weeks.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
* Adequate baseline laboratory parameters.
Exclusion Criteria
* History of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis.
* Second malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment, eg, prostate or breast cancer).
* Candidates for allogeneic stem cell transplant at the time of screening.
18 Years
ALL
No
Sponsors
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Seagen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Phillip Garfin
Role: STUDY_CHAIR
Seagen Inc.
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
University of Southern California
Los Angeles, California, United States
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
University of Colorado Hospital
Denver, Colorado, United States
Cancer Specialisits of North Florida
Fleming Island, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Georgia Regents University Hospital
Augusta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
University of Minnesota Medical Center (UMMC)
Minneapolis, Minnesota, United States
Bozeman Deaconess Health Group
Bozeman, Montana, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
The University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States
Weill Cornell
Brooklyn, New York, United States
Westchester Medical Center
Hawthorne, New York, United States
Columbia University Medical Center
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Case Western Reserve University (CWRU) - University Hospitals Case Medical Center
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Providence Portland Research Center
Portland, Oregon, United States
Oregon Health & Science
Portland, Oregon, United States
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Texas Oncology - Austin Midtown
Austin, Texas, United States
Baylor University Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Cancer Care Centers of South Texas
San Antonio, Texas, United States
Swedish Medical Center
Seattle, Washington, United States
Froedtert & Medical College of Wisconson Clinical Cancer Center
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SGN33A-004
Identifier Type: -
Identifier Source: org_study_id
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